Drug product
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
D-0628-2024
Product summary
- Event
- Event 94924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,200 cartons
- Official record key
drug-enforcement:D-0628-2024
Official wording
Reason: Defective container: potential for non-sealed pouches which can lead to product leakage.
Code information: Lot #S300542, exp. date June 30, 2025
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Unknown
Defective container: potential for non-sealed pouches which can lead to product leakage.